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How To Find The Best Potential Profit Plays In The Resurgent M&A And IPO Markets

Tue, 29 Sep 2009 13:52:15 GMT

When Xerox Corp. (NYSE: XRX) yesterday (Monday) unveiled plans to pay $6.4 billion for outsourcing specialist Affiliated Computer Services Inc. (NYSE: ACS), it was just one of four major financing deals with an aggregate value of more than $14 billion announced on the day.[More...]

FDA Calendar Updates: Orexo, Novo Nordisk, King, Isis, Facet

Mon, 10 Aug 2009 13:56:00 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 294 entries as of 8/6/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete (...)[More...]

Spotlight On: Biotech

Sun, 09 Aug 2009 19:06:17 GMT

Spotlight On: Biotech The U.S. biotechnology industry includes about 1,000 companies, of all sizes, with combined annual revenues close to $50 billion. Large companies include Amgen, Biogen Idec, Genetech, Genzyme, Life Technologies and Monsanto. Because so many drugs are now developed using biotechnology, the biotech and pharmaceutical industries overlap. Demand for biotechnology products and services is driven primarily by the willingness of insurers to pay for new medical treatments. With the pending introduction of Obamacare, new uncertainties are introduced to this industry. Biotech products and treatments tend to be expensive and the drive to reduce costs through rationing will no doubt effect this industry. The profitability of individual companies depends on the discovery and effective marketing of new products. Because the market for potential[More...]

FDA Calendar: EU Approval For NVO Diabetes Drug (NYSE:NVO)

Fri, 03 Jul 2009 14:39:00 GMT

Below is an update to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re- (...)[More...]

Best International Dividend Stocks

Wed, 10 Jun 2009 16:13:00 GMT

In a previous article I provided a list with the best dividend stocks for the long run. Since the list included only US stocks several readers asked for a similar list with international dividend growth stocks instead. Furthermore, I am also looking to expand my portfolio to include at least some allocation to [More...]

Global Pharma Favorites

Thu, 07 May 2009 15:05:39 GMT

In a review of the pharmaceutical sector, Chuck Carlson selects his favorite International stocks which also offer direct-purchase plans for U.S. investors. Here's a look at two of these stocks -- United Kingdom-based AstraZeneca (NYSE: AZN) and Denmark-based Novo Nordisk (NYSE: [More...]

FDA Calendar Updates - Diabetes: AZN, BMY, NVO

Thu, 23 Apr 2009 18:12:40 GMT

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA (...)[More...]

Carl Icahn V. Amylin Pharmacueticals Inc.

Mon, 20 Apr 2009 22:11:25 GMT

Normally I’d say woe to the CEO who crosses notoriously active investor Carl Icahn, but this time he might have met his match. Yes, other executives may have fallen to his ummm… persistent nature, but biotech Amylin Pharmaceuticals Inc. (Nasdaq: AMLN) lead independent director James Wilson, is having none of it. Along with strong shareholder Eastbourne Capital Management, Icahn has repeatedly attempted to stir up trouble at the company with the intent of changing the board of directors more to his liking. In Icahn’s case at least, the ultimate goal is to Amylin to sell itself to its diabetes drug partner Eli Lilly & Co. (NYSE: LLY). And as usual, he’s made no secret about his intentions. Then again, neither has[More...]

Market Report For Friday: Apr 17, 2009

Fri, 17 Apr 2009 13:00:45 GMT

(7:11am ET) There was plenty of economic data released in the US during the day; however the equity market sidetracked until 2pm ET, when with prices at modest losing levels on the week until that point, suddenly, and for no discernable reason, there was a rally that left the indexes with small gains through Thursday. Perhaps traders were anticipating a positive quarterly report from Google (GOOG +2.4% on +151% of average daily trading volume)? After the close, the company did not disappoint, beating both revenue and EPS estimates. The company posted net income of $1.42 billion ($5.16/share), up +8% from the $1.31 billion ($4.84/share) recorded during the same period a year ago. Revenue for 1Q2009 increased +10% to $4.07 billion, from $3.7 billion, excluding traffic acquisition costs. On average, analysts had expected earnings per share of $4.93 and revenue of $4.08 billion, according to Yahoo Finance. For the first[More...]

Biotech Industry - Industry Outlook

Thu, 16 Apr 2009 20:54:01 GMT

Last year, the Biotech industry as a whole achieved a much better performance than the market. Both the NASDAQ Biotech Index and AMEX Biotech Index outperformed all three major market indices (Dow Jones Industrial Average, NASDAQ Composite and S&P 500) in a large margin. The major indices declined as much as 40% while the NASDAQ Biotech Index declined only 12.6% and the AMEX Biotech Index was down 17.7%. However, when the recession enters into its third year, the Biotech industry is not doing better than the market, which has been evident by the indices' performances. As of April 9, 2009, AMEX Biotech Index declined 3%, and the broader NASDAQ Biotech Index was down 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies). Although the Dow and S&P 500 also declined a similar percentage, technology-laden NASDAQ actually has a gain of 4.8%, which is more comparable to the biotech indices. See[More...]

FDA issues advisory for Levemir insulin

Mon, 15 Jun 2009 19:31:00 GMT

FDA issues advisory for Levemir insulin[More...]

Olympia Dukakis urges diabetes screening

Mon, 18 May 2009 16:58:00 GMT

Olympia Dukakis urges diabetes screening[More...]

BRIEF: Triangle Companies Among 100 Best to Work For

Fri, 23 Jan 2009 10:12:00 GMT

Jan. 23--RESEARCH TRIANGLE PARK -- Network Appliance, a California technology company with about 1,000 employees at its RTP campus, ranks No.
1 on Fortune magazine's latest list of the "100 Best Companies to Work For."
Cisco Systems, which employs about 4,400 people in RTP, is No.

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Patient Education Summits to Address Special Challenges of Hemophilia Patients and Their Families

Thu, 27 Aug 2009 12:58:00 GMT

More than 160 families of patients living with a rare form of hemophilia are coming together at educational summits sponsored this fall by the National Hemophilia Foundation and the Center for Biomedical Continuing Education . For the fifth year, the Inhibitor Education Summits will connect patients and their families with expert healthcare professionals and fellow patients to address pertinent topics such as effective pain management, exercise and nutrition, financial security, and psychological wellbeing. The summits are supported by an educational grant from Novo Nordisk.[More...]

Dwayne Johnson, Novo Nordisk and the Entertainment Industry Foundation Educate Families about Healthy Living and Diabetes

Wed, 12 Aug 2009 13:56:00 GMT

Dwayne Johnson joins with Novo Nordisk, a world-leader in diabetes care, and the Entertainment Industry Foundation , a leading charitable organization of the entertainment industry, to encourage families to get active together as a means to help prevent diabetes. As an ambassador for the Diabetes Aware campaign, Johnson will appear in a public service announcement to educate families about the prevalence of diabetes and the importance of an active, healthy lifestyle.[More...]

Photos: Norditropin NordiFlex(R) 30 mg/3 mL Prefilled Pen Offers Children Needing a Larger Dose of Growth Hormone a Convenient Option

Mon, 10 Aug 2009 12:56:00 GMT

Today Novo Nordisk announced the availability of the Norditropin NordiFlex) 30 mg/3 mL, the only prefilled, preloaded pen that allows children who need a dose of growth hormone larger than 4.5 mg to take one injection instead of two. The pen holds twice the volume of, and has a higher maximum dose than, the 15 mg Norditropin NordiFlex) pen, offering a more convenient option for patients who require a growth hormone dose up to 6.0 mg.[More...]

Novo Nordisk: Half-Yearly Report

Thu, 06 Aug 2009 07:47:00 GMT

Interim financial report for the period 1 January 2009 to 30 June 2009
Sales increased by 17% in Danish kroner and by 11% in local currencies.
o Sales of modern insulins increased by 31% (25% in local currencies).

[More...]

Novo Nordisk Appoints Per Falk, M.D., Ph.D., as Vice President for Clinical, Medical and Regulatory Affairs for North America

Wed, 05 Aug 2009 12:26:00 GMT

Novo Nordisk, a global healthcare company focusing on diabetes care, today announced the appointment of Per Falk, M.D., Ph.D., as vice president for Clinical, Medical and Regulatory Affairs for North America. Dr. Falk joins the U.S. Executive Team and will report directly to Jerzy Gruhn, president of Novo Nordisk Inc., the Novo Nordisk U.S. affiliate, and senior vice president for Novo Nordisk A/S, North America.[More...]

Liraglutide Lowered Blood Sugar and Weight in African Americans With Type 2 Diabetes, Phase 3 Data Showed

Mon, 27 Jul 2009 14:55:00 GMT

LAS VEGAS, NV -- -- 07/27/09 -- Novo Nordisk data showed that when taken by itself, once-daily liraglutide, an investigational treatment for type 2 diabetes, leads to statistically significant and sustained reductions in blood sugar and weight in African Americans with type 2 diabetes, as compared to glimepiride, a commonly prescribed diabetes treatment. The data were presented at the 114th National Medical Association Annual Convention & Scientific Assembly.[More...]

Liraglutide Lowered Blood Sugar and Weight in African Americans With Type 2 Diabetes, Phase 3 Data Showed

Sat, 25 Jul 2009 13:05:00 GMT

LAS VEGAS, NV -- -- 07/25/09 -- Novo Nordisk data presented today showed that when taken by itself, once-daily liraglutide, an investigational treatment for type 2 diabetes, leads to statistically significant and sustained reductions in blood sugar and weight in African Americans with type 2 diabetes, as compared to glimepiride, a commonly prescribed diabetes treatment. The data were presented at the 114th National Medical Association Annual Convention & Scientific Assembly.[More...]

NCDP Health Care Reform Recommendations Advocate for Diabetes Prevention, Treatment and Care

Thu, 23 Jul 2009 12:58:00 GMT

The National Changing Diabetes) Program , a program of Novo Nordisk, and several member associations today urged President Obama and members of Congress to make the prevention, detection and treatment of diabetes, one of the nation's most pervasive and costly diseases, a priority in reforming the U.S. healthcare system.In an open letter to the President and lawmakers, NCDP said a national response to diabetes is required in order to transform health care and begin to ease the economic and personal burden of the disease, which is growing at an alarming rate. Today more than one in four Americans have diabetes or pre-diabetes, and these two conditions are estimated to have cost the U.S. $218 billion in 2007 in medical care and lost productivity, according to a recent study.Joining the NCDP in reaching out to lawmakers are the American Diabetes Association, the American College of Physicians and VSP.'We applaud the effort to reorient our health care system to focus more on the prevention of disease, and nowhere is the need greater than with diabetes,' said Dana Haza, senior director of NCDP, an initiative created by Novo Nordisk to drive health systems change at the national and local level. 'Not only does diabetes frequently result in devastating and costly complications, but diabetes also significantly increases the risk of heart disease, stroke, blindness, kidney disease, amputations and depression. So tackling diabetes early will make a huge impact on our nation's overall health care system.'Type 2 diabetes, the most prevalent form of the disease, can often be delayed or prevented. Data show that the risk of type 2 diabetes can be prevented or at least significantly delayed by losing even a modest amount of weight through diet and regular exercise. Further, other studies have shown that the onset and progression of eye, kidney and nerve complications resulting from diabetes can be delayed by keeping blood glucose levels as close to normal as possible.'We know that these lifestyle modifications and interventions work. Now we need to reform the health care system to promote them,' Haza said. The NCDP is calling on lawmakers to ensure diabetes is a top priority for health reform, including all new or expanded initiatives in public programs such as Medicare, Medicaid and CHIP. The organization said diabetes needs to be specifically identified as a priority condition for:Patient-centered care modelsChronic care management programsHealth information technology programsPrograms to reduce racial and ethnic disparities in health carePrevention and health promotion initiativesQuality improvement initiativesQuality-based incentivesMedicare and Medicaid demonstrations of new care models and delivery systems'We are facing a unique opportunity to profoundly change health care in America and improve the lives of countless people,' Haza said. 'Changing diabetes is essential to health care reform.'About the National Changing Diabetes) ProgramThe National Changing Diabetes) Program is a multi-faceted initiative that brings together leaders in diabetes and policy to improve the lives of people with diabetes. NCDP strives to create change in the U.S. health care system to provide dramatic improvement in the prevention and care of diabetes. Launched in 2005, NCDP is a program of Novo Nordisk. For more information, please visit www.ncdp.com. About Novo Nordisk Novo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. With headquarters in Denmark, Novo Nordisk employs more than 27,550 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.[More...]

FDA Approves NovoLog(R) Labeling Update

Wed, 15 Jul 2009 17:38:00 GMT

Diabetes patients taking NovoLog) can now use the insulin in their pump for up to six days following the U.S. Food and Drug Administration approval of a labeling change, diabetes care company Novo Nordisk announced today. The previous label allowed for NovoLog) to be stored in the pump reservoir for two days. This makes NovoLog) the first and only rapid-acting insulin with this extended in-use time. An insulin pump is a small, battery powered device designed to constantly deliver insulin into the patient's body 24 hours a day according to a preset program. Approximately the size of a pager, the pump system is composed of a reservoir for the insulin, a small battery, the pump, and a thin plastic tube with a needle on the end that passes insulin into the body, called the infusion set. The updated NovoLog) label also states that patients using NovoLog) in their pumps should change the infusion set and the infusion set insertion site at least every three days. The previous label stated that NovoLog) in the pump reservoir, infusion set and the infusion set insertion site be changed at least every 48 hours. The revised label keeps the same recommendation that NovoLog) should be discarded after exposure to temperatures that exceed 37 degrees C . 'The ability to go longer between changes of insulin in the pump allows people with diabetes to have more active and flexible lifestyles, which are integral to the success of long-term diabetes management,' said Richard R. Rubin, PhD, professor, medicine and pediatrics, The Johns Hopkins University School of Medicine. The label change is based on the FDA's review of data from Novo Nordisk that showed the stability of NovoLog) in the pump for up to six days.NovoLog) is a rapid-acting insulin analog, meaning it works faster and for a shorter period of time compared with regular human insulin. NovoLog) is also available in FlexPen), the world's #1 selling prefilled insulin pen. Diabetes patients who take NovoLog) can eat within 5-10 minutes of use, rather than the typical 30 minutes required with regular human insulin.NovoLog) was first approved by the FDA in 2000 and approved for use in pumps in 2001. Prescribing information for NovoLog) is available by contacting Novo Nordisk or visiting http://www.novolog.com.About NovoLog NovoLog is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus. Important Safety InformationDo not take NovoLog if your blood sugar is too low or if you are allergic to anything in NovoLog. If you take too much NovoLog your blood sugar may fall too low. NovoLog is a fast-acting insulin. You should eat a meal within 5 to 10 minutes after using NovoLog to avoid low blood sugar. Do not inject NovoLog if you do not plan to eat right after using NovoLog. Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog.Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin. Do not mix NovoLog with any other insulins when used in a pump or with any insulins other than NPH when used with injections by syringe. Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your NovoLog dose may change if you take other medicines.NovoLog has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.The most common side effect of NovoLog is low blood sugar . Other possible side effects include reactions at the injection site , and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.About Novo NordiskNovo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 27,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit www.novonordisk-us.com. Revised NovoLog Prescribing Information. 'Dosage and Administration.' Section 2.3. 'Continuous subcutaneous insulin infusion by external pump.'NovoLog is a registered trademark of Novo Nordisk A/S.[More...]

Diabetes Advocates Call For National Strategy, Leadership to Reduce Diabetes and Advance Detection and Treatment

Mon, 13 Jul 2009 17:46:00 GMT

The National Changing Diabetes) Program recently called for the creation of a National Diabetes Coordinator to develop and implement a nationwide strategy to reduce the incidence of diabetes and its devastating complications. A study commissioned by NCDP showed that 18 of 21 federal agencies impact the disease of diabetes. The coordinator would be responsible for establishing priorities in the fight against diabetes and aligning efforts across all agencies to eliminate duplication and maximize impact.'While mortality rates of major diseases such as cancer, heart disease and stroke are down, diabetes rates continue to rise,' said Dana Haza, Senior Director of the NCDP, an initiative created by Novo Nordisk to drive systems change at the national and local level. "It is impossible for 18 agencies to coordinate a response without designated oversight and leadership. That's why we must take immediate action to align all diabetes efforts with a national strategy if we are going to succeed in the fight against this costly and debilitating illness.'The NCDP launched an e-petition so that the diabetes community can voice its support for new government leadership dedicated to fighting diabetes and pre-diabetes, which cost the nation more than $218 billion each year in medical expenses and lost productivity. The e-petition, which is targeted to Congress and the Obama Administration and is designed to show a groundswell of support for a National Diabetes Coordinator, is available at www.ncdp.com/coordinator.'There is no doubt that diabetes is an epidemic that needs to be addressed at the highest levels of government,' Haza said. 'Today there are 24 million Americans diagnosed with diabetes and another 57 million with pre-diabetes.'The coordinator would be responsible for developing and implementing a national strategy to reduce the incidence, progression and impact of diabetes by linking government agencies with public and private sector efforts. This coordination would extend across federal and state levels to community public health agencies."By harnessing all these government resources, we will be able to increase detection of diabetes and improve the care of those who have the disease, maximize treatment and research into new medicines, and work aggressively to prevent the disease in populations at greatest risk," said Lana Vukovljak, Chief Executive Officer at the American Association of Diabetes Educators. "All this will be done with an eye toward saving taxpayers money through better alignment of government resources.Among the NCDP member associations in support of the National Diabetes Coordinator position are The American Diabetes Association , American Association of Diabetes Educators , American Association of Clinical Endocrinologists , American Academy of Family Physicians and American Optometric Association .'The social and economic costs of diabetes are staggering to American patients, families, and humanity as a whole. A National Diabetes Coordinator will help ensure coordination of diabetes research, education and outreach efforts across the spectrum of federal agencies.'Ted Epperly, MDPresident, AAFP'Our hope is that the creation of a National Diabetes Coordinator will provide the leadership necessary to promote and encourage early diagnosis and treatment, and efficiently and effectively reduce the incidence, progression and impact of diabetes - ultimately saving lives, America's vision and taxpayer resources.'Peter H. Kehoe, O.D.President, AOAAbout DiabetesKnown as the 'silent killer,' diabetes is the fifth-deadliest disease in the U.S. In addition to its effects on the nation's health, diabetes also takes a toll on the economy. The direct and indirect economic costs for diagnosed diabetes, undiagnosed diabetes, pre-diabetes and gestational diabetes in 2007 were an estimated $218 billion, according to a recent Lewin Group study commissioned by NCDP. In 2005, the federal government spent nearly $80 billion on diabetes treatment, with only $4 billion of this amount invested in prevention and health promotion.Nearly 24 million Americans have diabetes and another 57 million have pre-diabetes. Research shows that a child born after the year 2000 has a one in three chance of developing diabetes, and minority children have a one in two chance of developing diabetes.About the National Changing Diabetes) ProgramThe National Changing Diabetes) Program is a multi-faceted initiative that brings together leaders in diabetes and policy to improve the lives of people with diabetes. NCDP strives to create change in the U.S. health care system to provide dramatic improvement in the prevention and care of diabetes. Launched in 2005, NCDP is a program of Novo Nordisk. For more information, please visit www.ncdp.com. About Novo NordiskNovo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. With headquarters in Denmark, Novo Nordisk employs more than 27,550 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.[More...]